ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID

{0}------------------------------------------------ # 510(k) Summary: Oral Fluid Amphetamine Assay | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. MAY - 3 2011 | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Name, Address, Contact | Roche Diagnostics<br>9115 Hague Rd.<br>Indianapolis, IN 46250<br>317-521-3742<br><br>Contact Person: Michelle Neff<br>Date Prepared: April 11, 2011 | | Device Name | Proprietary name: Oral Fluid Amphetamine Assay<br><br>Common name: Amphetamine test system<br><br>Classification name: Enzyme Immunoassay, Amphetamine<br><br>Product Code: DKZ | | Device Description | The DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.<br><br>Multi-analyte calibrator and control solutions are prepared from NIST traceable, commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically in a synthetic oral fluid matrix at the following concentrations: 0, 20, 40, 80, 160, and 320 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS. | K116446 {1}------------------------------------------------ DAT Oral Fluid Amphetamine (OFAMP) is an in vitro diagnostic test for the Intended Use qualitative and semiquantitative detection of amphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS. > DAT Oral Fluid Amphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. > The Oral Fluid DAT Control Set B is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device. · The Oral Fluid DAT Qual Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept® Oral Specimen Collection Device. The Oral Fluid DAT SQ Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept® Oral Specimen Collection Device, Comparison to Predicate Device The Oral Fluid Amphetamine assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, we claim substantial equivalence to the currently marketed Amphetamine-Specific Intercept® Micro-Plate EIA assay (K992918). | Feature | Roche Oral Fluid Amphetamine Assay | Predicate Device: Amphetamine-<br>Specific Intercept® MICRO-<br>PLATE EIA (K992918) | |--------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Methodology | KIMS, Kinetic interaction of microparticles in<br>solution | Competitive micro-plate immunoassay | | Sample Type | Oral Fluid | Oral Fluid | | Intended Use | Qualitative and semi-quantitative detection of<br>Amphetamine | Qualitative detection of<br>Amphetamines | | Neat Cutoff | 120 ng/mL in Neat Oral Fluid | 100 ng/mL when oral fluid collected<br>with the Oral Specimen Collection<br>Device | | Controls | Synthetic oral fluid matrix:<br>Zero, Negative (.5X), and Positive (1.5X) | Synthetic oral fluid matrix:<br>Negative (.5X) and Positive (2X) | | Calibrator | Synthetic oral fluid matrix:<br>Zero, .5X, Cutoff, 2X, 4X, and 8X | Synthetic oral fluid matrix:<br>Zero, Cutoff | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 3 2011 HAY Roche Diagnostics c/o Ms. Michelle Lee Neff Regulatory Affairs Principal 9115 Hague Road, PO Box 50416 Indianapolis, IN, 46250-0416 Re: k110446 > Trade Name: DAT Oral Fluid Amphetamine Assay, Oral Fluid DAT Qual Cal B. Oral Fluid DAT SQ Cal B and Oral Fluid DAT Control Set B Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ, DKB, DIF Dated: February 15, 2011 Received: February 16, 2011 ### Dear Ms. Neff: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 {3}------------------------------------------------ Page 2 - If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 C.F.R.) 5450 - Also, places not other of In Vitro Diagnostic Device Evaluation and Safety at (301 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the Act Trim the (800) 638-2041 or (201) 706-7140 - entity In 1 consumer Assistance at its (800) 638-2041 or (301) 796-7100 or at its Internet and Consume http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, C.C. Courthey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure ・・・・・ {4}------------------------------------------------ ## Indication for Use #### KII 0446 510(k) Number (if known): Device Name: Oral Fluid Amphetamine Indication For Use: DAT Oral Fluid Amphetamine (OFAMP) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine in human oral fluid at a cutoff concentration of 120 ng/ml in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS. DAT Oral Fluid Amphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Oral Fluid DAT Control Set B is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept" Oral Specimen Collection Device. The Oral Fluid DAT Qual Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept@ Oral Specimen Collection Device. The Oral Fluid DAT SQ Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device. Prescription Use _ XXX (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C) ### (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) R Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K110446